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Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00321620
Recruitment Status : Completed
First Posted : May 4, 2006
Results First Posted : March 21, 2014
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer

Condition or disease Intervention/treatment Phase
Bone Metastases Drug: zoledronic acid Biological: denosumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1904 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer
Study Start Date : April 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : February 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: zoledronic acid Drug: zoledronic acid
Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
Other Name: Zometa
Experimental: denosumab Biological: denosumab
Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes


Outcome Measures
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Primary Outcome Measures :
  1. Time to the First On-Study SRE (Non-inferiority) [ Time Frame: Up to 40.5 months ]
    Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.


Secondary Outcome Measures :
  1. Time to the First On-Study SRE (Superiority) [ Time Frame: Up to 40.5 months ]
    Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.

  2. Time to the First-And-Subsequent On-Study SRE [ Time Frame: Up to 40.5 months ]

    Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.

    This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men >/= 18 years of age with histologically confirmed prostate cancer
  • Radiographic evidence of at least one bone metastasis
  • Failure of at least one hormonal therapy as evidenced by a rising PSA
  • Serum testosterone level of <50 ng/dL
  • ECOG PS 0, 1, or 2
  • Adequate organ function

Exclusion Criteria:

  • Current or prior IV bisphosphonate administration
  • Current or prior oral bisphosphonates for bone mets
  • Life expectancy of less than 6 months
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321620


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00321620     History of Changes
Other Study ID Numbers: 20050103
First Posted: May 4, 2006    Key Record Dates
Results First Posted: March 21, 2014
Last Update Posted: March 21, 2016
Last Verified: February 2016

Keywords provided by Amgen:
Bone metastases
Hormone-refractory prostate cancer
Skeletal
 Fractures
Compressions
Bisphosphonates

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
 Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Hormones
Zoledronic acid
Diphosphonates
Denosumab
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents